Autoimmune EncephalitisPhase 4NCT03004209
Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients
A Phase 4 study testing Erythropoietin in people with Autoimmune Encephalitis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study evaluates the efficacy of erythropoietin in refractory autoimmune encephalitis. Ten patients will receive 100 IU/kg of erythropoietin 3 times a week for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Autoimmune Encephalitis
- What is being tested?
- Erythropoietin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2016to 6 Feb 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed autoimmune encephalitis
- Ineffective 1st line treatment (e.g. steroid IV, IVIg) and 2nd line treatment (e.g. Rituximab or cyclophosphamide)
Who cannot join
- Hemoglobin > 12g/dL
- Hematochrit >36%
- Thrombocytosis > 750K
- AST or ALT > 120
- HIV (+)
- Allergic reaction upon erythropoietin
Show all 11Show fewer
- Uncontrolled hypertension
- mRS before the autoimmune encephalitis > 3
- Breast feeding or pregnancy
- History of ischemic stroke or pulmonary thrombosis
- Refuse to be enrolled
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the efficacy of erythropoietin in refractory autoimmune encephalitis. Ten patients will receive 100 IU/kg of erythropoietin 3 times a week for 12 weeks.
Read the detailed description
Erythropoietin can improve the refractory autoimmune encephalitis. Erythropoietin has tissue-protective effect via activation of Janus kinase (JAK)-2, signal transducer and activator of transcription (STAT)-5 pathway and NF-kappa B pathway. The activation of JAK-2 and STAT-5 promote hemoglobin synthesis and facilitate cell cycle progression. Also, NF-kappa B pathway inhibition regulates pro-inflammatory cytokine production.
We expect that erythropoietin may lead to improve the symptoms and outcome of autoimmune encephalitis.
- Conditions
- Autoimmune Encephalitis
- Being tested
- Erythropoietin
- Keywords
- Erythropoietin, Autoimmune encephalitis
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythropoietinDrug
Also called Epokine prefilled injection
three times per a week 100IU / k
| Study group | Role | What they receive |
|---|---|---|
| EPO | Other | Erythropoietin injection: three times per a week, 100 IU/kg for each patients Trade name: epokine prefilled injection Receives: Drug: Erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline modified Rankin Scale (mRS) at 12th week
Favorable outcome is an improvement of mRS score.
Measured: 2nd week, 12th week
Secondary outcomes (3)
Adverse effect
Common terminology criteria for adverse events (CTCAE) 4.0
Measured: 2nd week, 4th week, 8th week, 12th week
Quality of Life in Epilepsy Inventory (QOLIE) -31
Measured: 2nd week, 4th week, 8th week, 12th week
Mini-Mental State Examination (MMSE)
Measured: 2nd week, 4th week, 8th week, 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion6 Feb 2018
- Study completion6 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune EncephalitisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kon Chu, Seoul National University Hospital
- Investigators
- Kon Chu, Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004209
- Sponsor's protocol ID
- 1607-120-777
- Status last verified
- Sep 2021
- First submitted
- 21 Dec 2016
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients
- ClinicalTrials.gov ID
- NCT03004209
- Acronym / sponsor ID
- 1607-120-777
- Conditions
- Autoimmune Encephalitis
- Keywords
- Erythropoietin, Autoimmune encephalitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- 6 Feb 2018 (actual)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy of erythropoietin in refractory autoimmune encephalitis. Ten patients will receive 100 IU/kg of erythropoietin 3 times a week for 12 weeks.
Detailed description
Erythropoietin can improve the refractory autoimmune encephalitis. Erythropoietin has tissue-protective effect via activation of Janus kinase (JAK)-2, signal transducer and activator of transcription (STAT)-5 pathway and NF-kappa B pathway. The activation of JAK-2 and STAT-5 promote hemoglobin synthesis and facilitate cell cycle progression. Also, NF-kappa B pathway inhibition regulates pro-inflammatory cytokine production.
We expect that erythropoietin may lead to improve the symptoms and outcome of autoimmune encephalitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPO | Other | Drug: ErythropoietinErythropoietin injection: three times per a week, 100 IU/kg for each patients Trade name: epokine prefilled injection |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically diagnosed autoimmune encephalitis
- Ineffective 1st line treatment (e.g. steroid IV, IVIg) and 2nd line treatment (e.g. Rituximab or cyclophosphamide)
Key exclusion criteria (11 listed)
- Hemoglobin > 12g/dL
- Hematochrit >36%
- Thrombocytosis > 750K
- AST or ALT > 120
- HIV (+)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErythropoietinAlso: Epokine prefilled injectionthree times per a week 100IU / k | Drug | EPO |
Primary outcome
Change from Baseline modified Rankin Scale (mRS) at 12th week
Time frame: 2nd week, 12th week
Favorable outcome is an improvement of mRS score.
3 secondary outcomes
Adverse effect
Time frame: 2nd week, 4th week, 8th week, 12th week
Quality of Life in Epilepsy Inventory (QOLIE) -31
Time frame: 2nd week, 4th week, 8th week, 12th week
Mini-Mental State Examination (MMSE)
Time frame: 2nd week, 4th week, 8th week, 12th week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kon Chu, Ph.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erythropoietin in people with Autoimmune Encephalitis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline modified Rankin Scale (mRS) at 12th week (time frame: 2nd week, 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.